Effect of Vitamin D Treatment in Primary Hyperparathyroidism

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
First received: May 5, 2008
Last updated: October 23, 2013
Last verified: August 2013
The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Condition Intervention Phase
Vitamin D Deficiency
Primary Hyperparathyroidism
Drug: Cholecalciferol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Decrease in Preoperative P-PTH [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.

Secondary Outcome Measures:
  • Improved Muscular Function [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Reduced Postoperative Hypocalcemia [ Time Frame: Postoperative week ] [ Designated as safety issue: No ]
  • Increase in Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Increased Bone Mineral Density [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D group
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Name: vitamin D
Placebo Comparator: Placebo group
Placebo, two tablets daily in 52 weeks.
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Name: vitamin D

Detailed Description:
The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • P-Ca-ion > 1,30 mmol/l
  • P-PTH > 5 pmol/l
  • P-OH25-vitamin D < 80 nmol/l

Exclusion Criteria:

  • P-creatinin > 120 mumol/l
  • usage of Etalpha, Mimpara
  • Cancer
  • Sarcoidosis
  • malabsorption
  • pancreatitis
  • alcohol abuse
  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00674154

Osteoporoseklinikken, Aarhus University Hospital, THG
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Lars Rolighed, MD
Study Director: Lars Rejnmark, MD,PhD,DrMed
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00674154     History of Changes
Other Study ID Numbers: PHPT-20080011 
Study First Received: May 5, 2008
Results First Received: August 6, 2013
Last Updated: October 23, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Vitamin D
Primary hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Vitamin D Deficiency
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Metabolic Diseases
Nutrition Disorders
Parathyroid Diseases
Water-Electrolyte Imbalance
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016